{"doc_desc":{"title":"Cohort of Patients with Primary Bronchial Lung Cancer","idno":"FRESH-PEF73306-en","producers":[{"name":"Grimaux MICHEL","affiliation":"GRAND HOPITAL DE L EST FRANCILIEN (GHEF)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73306-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73306"},{"agency":"FReSH","code":"FRESH-PEF73306"}]},"title":"Cohort of Patients with Primary Bronchial Lung Cancer","alternate_title":"KBP-CPHG"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Michel;GRIVAUX","PILabo":"Meaux Hospital \/ Pulmonology","affiliationName":"GRAND HOPITAL DE L EST FRANCILIEN (GHEF)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"084261285","role":"pi id"},{"title":"SIREN","uri":"200063477","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"m-grivaux@ch-meaux.fr","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"COLLEGE PNEUMOLOGUES HOPITAUX GENERAUX (CPHG)","extlink":[{"title":"SIREN","uri":"413350554","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"ASTRAZENECA (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016qv5070"},{"title":"SIREN","uri":"558201075"}]},{"name":"BOEHRINGER INGELHEIM INTERNATIONAL GMBH","extlink":[{"title":"SIREN","uri":"508241882"}]},{"name":"CHUGAI PHARMA FRANCE","extlink":[{"title":"SIREN","uri":"435074422"}]},{"name":"COLLEGE PNEUMOLOGUES HOPITAUX GENERAUX (CPHG)","extlink":[]},{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140"}]},{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87"},{"title":"SIREN","uri":"592052146"}]},{"name":"LILLY FRANCE","extlink":[{"title":"SIREN","uri":"609849153"}]},{"name":"PFIZER (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02c9yny10"},{"title":"SIREN","uri":"433623550"}]},{"name":"PIERRE FABRE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04hdhz511"}]},{"name":"RECHERCHE EN SANTE RESPIRATOIRE (FOND DE DOTATION)","extlink":[{"title":"SIREN","uri":"521979674"}]},{"name":"SANOFI (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837"},{"title":"SIREN","uri":"395030844"}]},{"name":"SARL PNEUMOLOGIE DEVELOPPEMENT","extlink":[{"title":"SIREN","uri":"410753727"}]}]},"distribution_statement":{"contact":[{"name":"Michel;GRIVAUX","email":"m-grivaux@ch-meaux.fr","type":"contact","affiliationName":"GRAND HOPITAL DE L EST FRANCILIEN (GHEF)","contactPointLabo":"","extlink":[{"uri":"200063477","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"general hospitals"},{"keyword":"adenocarcinoma"},{"keyword":"bronchopulmonary cancer (BPC)"},{"keyword":"patient treatment"},{"keyword":"epidemiology"}],"topics":[{"topic":"Oncology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D008495"}]},{"topic":"Pulmonary medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/f6e18c52-6087-4662-904c-5c4b8174e40e"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D015272"}]},{"topic":"Malignant neoplasms of bronchus or lung","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/316539081","title":"CIM-11"}]},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Biological determinants: Genetic predisposition","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Biological determinants","vocab":"health determinant"}],"purpose":"The main aim is to study patient mortality at 5 years and risk factors. Secondary aims are: \u2013 to describe the characteristics in this patient population, their cancer and treatment methods; \u2013 to estimate the survival rate at 1, 4 and 5 years; \u2013 to compare data obtained with data from the KBP-2000-CPHG study (same study type, centre and patient recruitment methods, patient inclusion criteria and several common items in both questionnaires).","abstract":"","coll_dates":[{"start":"2000-01-01","end":"2010-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"All patients with histological and cytological BPC diagnosed between 01 January and 31 December 2000 and 01 January and 31 December 2010. Patients monitored by the pulmonology unit in one of the general hospitals centres (GHC).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}","{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[10000-20000[ individuals","response_rate":"2000: 4,669; 2010: 7,051"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"21-01-2016","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":"No","contributorName":"Michel GRIVAUX","contributorAffiliation":"GRAND HOPITAL DE L EST FRANCILIEN (GHEF)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=KBP+AND+CPHG"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry","Industry","Industry","Other","Industry","Industry","Industry","Industry","Industry","Other","Industry","Other"],"otherFundingAgentType":["","","","","","","","","","","",""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"By participating physicians.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"BPC diagnostic methods (recruitment, symptoms, radiography, sampling method and sample location that led to diagnosis, date of diagnosis, anatomopathological test); functional status based on Performance Status (PS) score; BPC histological type according to World Health Organisation classification and obtained from histological or cytological results (small-cell carcinoma, adenocarcinoma, squamous-cell carcinoma, large-cell carcinoma, bronchioloalveolar carcinoma); cancer stage at time of diagnosis based on Tumor-Node-Metastasis [TNM] clinical NSCLC classification according to the Mountain criteria; treatment strategies and initial therapy chosen by physician.","biologicalDataDetails":"","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}